Although drug therapy usually is not as effective as surgical therapy, it may provide adequate symptomatic relief with fewer and less serious adverse effects compared with surgery.14

May consider combined therapy with an α1-adrenergic blocker and 5α-reductase inhibitor for men with bothersome moderate to severe BPH and demonstrable prostatic enlargement.14 Has been more effective than therapy with either drug alone in preventing long-term BPH symptom progression.14 Men at risk for BPH progression are most likely to benefit from combination therapy.14

Other Uses

Manufacturer states that alfuzosin should not be used for the treatment of hypertension.1

Uroxatral Dosage and Administration

Administration

Oral Administration

Administer orally once daily immediately after the same meal each day.1

Do not chew or crush tablets.1

Dosage

Available as alfuzosin hydrochloride; dosage is expressed in terms of the salt.1

Intraoperative Floppy Iris Syndrome

If patient has received α1-adrenergic blockers, ophthalmologist should be prepared to modify the surgical technique (e.g., through use of iris hooks, iris dilator rings, or viscoelastic substances) to minimize complications of IFIS.1 There does not appear to be a benefit from discontinuing α1-blocker therapy prior to cataract surgery.1

Coronary Insufficiency

If new or worsening symptoms of angina pectoris occur, discontinue therapy.1

Congenital or Acquired QT-Interval Prolongation

Modest QT-interval prolongation possible.1

Consider potential for QT-interval prolongation in patients with known history of QT-interval prolongation and/or in those receiving concomitant therapy with drugs known to prolong QT interval.1

Specific Populations

Pregnancy

Category B.1

Not indicated for use in women.1

Lactation

Not indicated for use in women.1

Pediatric Use

Not indicated for use in children.1

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.1

Hepatic Impairment

Use not recommended in patients with moderate to severe hepatic impairment.1 Not studied in patients with mild hepatic impairment.1

Distribution

Plasma Protein Binding

Elimination

Metabolism

CYP3A4 is the principal hepatic isoenzyme involved in the drug’s metabolism.1

Elimination Route

Excreted in feces (69%) and urine (24%) as unchanged drug and metabolites.1

Half-life

10 hours.1

Special Populations

In patient with moderate to severe hepatic impairment, plasma alfuzosin concentrations are 3- to 4-fold higher than in healthy individuals; pharmacokinetics not studied in patients with mild hepatic impairment.1

In patient with mild to severe renal impairment, AUC is 50% higher than in healthy individuals.1

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).1 Protect from moisture and light.1

Actions

Blocks α1-adrenergic receptors in the lower urinary tract to cause relaxation of smooth muscle in the bladder neck and prostate and improve symptoms of BPH (e.g., urine flow).1

Advice to Patients

Risk of feeling faint or dizzy, particularly following initiation of therapy; avoid situations where injury could result if syncope occurs.1

Importance of exercising caution when driving or operating machinery.1

Importance of taking alfuzosin exactly as prescribed.1 Importance of taking alfuzosin with the same meal each day and of not chewing or crushing the tablets.1

Importance of advising male patients being considered for cataract surgery that they should inform their ophthalmologist of current or prior α1-blocker (e.g., alfuzosin) therapy.1

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.1

Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.